Phase 3 N=1,042 Randomized Prevention

Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus · Whooping Cough · Meningitis

Bottom Line

View on ClinicalTrials.gov: NCT00325130 ↗

Enrolled (actual)

1,042

Serious AEs

—

Results posted

Jul 2009

Primary outcome: Primary: Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) — 416; 417 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine (Biological); Comparator: Menactra™ (Concomitant) (Biological); Comparator: Adacel™ (Concomitant) (Biological); Comparator: Menactra™ (Non-concomitant) (Biological); Comparator: Adacel™ (Biological)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Apr 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)	416; 417	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)	418; 418	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)	421; 420	<0.001 sig
PRIMARY Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)	421; 420	<0.001 sig
PRIMARY Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™	367; 345	<0.001 sig
PRIMARY Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™	423; 394	<0.001 sig
PRIMARY Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™	429; 394	<0.001 sig
PRIMARY Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™	414; 404	<0.001 sig
PRIMARY Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	397; 381	<0.001 sig
PRIMARY Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	398; 384	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1349.3; 1340.8	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1609.6; 1513.7	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™	7203.0; 7370.0	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™	1270.2; 1425.3	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	18.5; 19.3	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	132.5; 150.9	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	253.6; 274.2	<0.001 sig
PRIMARY Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™	703.0; 611.2	<0.001 sig
SECONDARY Acceptable Safety Profile	—	—

Summary

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Eligibility Criteria

Inclusion Criteria

Must be healthy boys or girls, 11-17 years of age
Must be a virgin with no intention of becoming sexually active during the study period
Must have been properly vaccinated against diphtheria, tetanus and pertussis

Exclusion Criteria

Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years
Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00325130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.